MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; ENZYMATIC METHOD, CREATININE

Catalog Number 03263991190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 5 patients' samples tested with creatinine gen.2 (crep2) assay on a cobas integra 400 plus analyzer.Sample 1: initial result: 100.5 umol/l.Repeat result: 62.3 umol/l.Sample 2: initial result: 108.1 umol/l.Repeat result: 62.6 umol/l.Sample 3: initial result: 141.0 umol/l.Repeat result: 95.7 umol/l.Sample 4 and sample 5 were tested on (b)(6) 2024: sample 4: initial result: 115.0 umol/l.Repeat result: 63.6 umol/l.Sample 5: initial result: 111.1 umol/l.Repeat result: 88.6 umol/l.The initial results were reported to the client who compared them to results they had from another laboratory.The client questioned the results as they did not match with the other laboratory's results.The samples were then repeated.The repeat results were deemed to be correct.

Manufacturer Narrative

The cobas integra 400 plus analyzer serial number was (b)(6).Qc within the assigned ranges on the day of the event.The customer stated that they replaced the probes.The investigation is ongoing.

Manufacturer Narrative

The customer alleged discrepant results for an additional patient sample tested on (b)(6)2024: sample 6: initial result: 115.0 mol/l.Repeat result: 63.6 mol/l.A general reagent issue can be excluded because calibration and qc were acceptable.The extra wash cycles were correctly installed.The required data for the investigation was requested but not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18861210
• MDR Text Key: 337189738
• Report Number: 1823260-2024-00701
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): Y
• Reporter Country Code: SF
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03263991190
• Device Lot Number: 74766501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1